Progesterone may reduce the risk of disability and death in persons who have sustained moderate traumatic brain injury (TBI). The first double-blind placebo-controlled safety trial of the agent in humans showed that progesterone was safe, being associated with no more adverse effects than placebo.
Progesterone may reduce the risk of disability and death in persons who have sustained moderate traumatic brain injury (TBI). The first double-blind placebo-controlled safety trial of the agent in humans showed that progesterone was safe, being associated with no more adverse effects than placebo. Furthermore, the rate of death among treated patients was half of that of untreated patients. Those patients with moderate injury who received progesterone had better outcomes than untreated patients.
The study included 100 adult patients who arrived for treatment at an urban trauma center within 11 hours of injury and who had postresuscitation Glasgow Coma Scales (GCS) scores of 4 to 12. Patients were enrolled by proxy consent and were randomly selected on a 4-to-1 basis to receive either intravenous progesterone (n=77) or placebo (n=23). The researchers, led by Donald Stein, PhD, the Asa G. Candler Professor of Psychology, Emergency Medicine and Neurology at Emory University in Atlanta, noted that outcomes were similar between groups except that the 30-day postinjury mortality rate was lower for the group that received progesterone. GCS-Extended and Disability Rates Scale scores were generally poor at 30 days regardless of whether patients received progesterone or placebo; however, those patients with moderate injury who received progesterone were more likely to have a moderate to good outcome compared with peers who received placebo.
Stein and colleagues already have shown in a number of studies that less brain swelling occurs and recovery is more complete in rat models of TBI that are treated with progesterone shortly after injury. "The hormone seems to slow or block damaging chemicals that are released after a brain injury, protecting the brain from the death of brain cells," Stein explained. This small study suggests that progesterone does not harm and may be of benefit in a subgroup of patients.
The current citation for this study is Wright DW, Kellermann AL, Hertzberg VS, et al. ProTECT: a randomized clinical trial of progesterone for acute traumatic brain injury. Ann Emerg Med. 2006 Sept 28; [Epub ahead of print].